Study Results
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View full resultsBasic Information
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COMPLETED
NA
720 participants
INTERVENTIONAL
2017-01-09
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Discontinuation
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Discontinuation of Overused Medication
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
Preventive Therapy Only
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Migraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Interventions
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Migraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Discontinuation of Overused Medication
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy
Eligibility Criteria
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Inclusion Criteria
* Chronic Migraine - diagnosed according to ICHD3beta criteria
* Medication Overuse - diagnosed according to ICHD3beta criteria
* Willingness to be randomized to either of the two treatment arms
* Willingness to maintain a headache diary
* Plan for follow-up care with the clinician
* No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
Exclusion Criteria
* Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
* Not willing to be randomized to either of the treatment arms
* Not willing to maintain a daily headache diary
* Not planning on follow-up care with the clinician
* In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
* Prisoners
* Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
21 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Mayo Clinic
OTHER
Responsible Party
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Todd J. Schwedt
PI
Principal Investigators
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Todd J Schwedt, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
David W Dodick, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Northern Arizona Healthcare Medical Group
Flagstaff, Arizona, United States
Mayo Clinic in Arizona Headache Center
Phoenix, Arizona, United States
Mayo Clinic in Arizona Neurology Center
Phoenix, Arizona, United States
Honor Health Neurology
Scottsdale, Arizona, United States
Mayo Clinic Thunderbird
Scottsdale, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
University of Colorado Denver Headache Center
Aurora, Colorado, United States
University of Colorado Denver Primary Center
Denver, Colorado, United States
Blue Sky Neurology
Greenwood Village, Colorado, United States
Memorial Healthcare
Hollywood, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Norton Neurology
Louisville, Kentucky, United States
Brigham Women's Hospital Headache Clinic
Boston, Massachusetts, United States
Brigham Women's Hospital Neurology Clinic
Boston, Massachusetts, United States
Henry Ford Allegiance Health
Jackson, Michigan, United States
Mayo Clinic Headache Center
Rochester, Minnesota, United States
The Headache Center
Ridgeland, Mississippi, United States
Clinvest Research
Springfield, Missouri, United States
University of Cincinnati Neurology
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Cincinnati Headache Center
Dayton, Ohio, United States
Toledo Clinic Adult Neurology
Toledo, Ohio, United States
Thomas Jefferson University Hospital Headache Center
Philadelphia, Pennsylvania, United States
Preferred Headache Center
Pittsburgh, Pennsylvania, United States
University of Utah Primary Care
Salt Lake City, Utah, United States
University of Utah General Neurology
Salt Lake City, Utah, United States
University of Utah Headache Center
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
West Virginia University Neurology
Morgantown, West Virginia, United States
Countries
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References
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Whitaker DJ, Dumkrieger GM, Hentz JG, Dodick DW, Schwedt TJ. Physical impairment during and between migraine attacks: A daily diary study of patients with chronic migraine. Cephalalgia. 2024 Apr;44(4):3331024241249747. doi: 10.1177/03331024241249747.
Schwedt TJ, Hentz JG, Sahai-Srivastava S, Murinova N, Spare NM, Treppendahl C, Martin VT, Birlea M, Digre K, Watson D, Leonard M, Robert T, Dodick DW; MOTS Investigators. Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial. Neurology. 2022 Apr 5;98(14):e1409-e1421. doi: 10.1212/WNL.0000000000200117. Epub 2022 Feb 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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PCORI
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
16-001036
Identifier Type: -
Identifier Source: org_study_id